Phase 3, multicenter, multinational, double-blind, randomized (2:1), placebo-controlled
Topic / Pathology
- SLA
- Phase 3
Objectives
Primary objective
To evaluate the effect of FAB122 100 mg treatment on disease progression in ALS patients.
Secondary objectives
1. Evaluate the effect of FAB122 treatment on survival
2. Evaluate the safety and tolerability of FAB122
3. Evaluate the effect of FAB122 treatment on quality of life (QoL)
4. Evaluate the effect of FAB122 treatment on cognitive functioning
5. To evaluate the pharmacokinetics (PK) of FAB122.
Find out more : https://clinicaltrials.gov/ct2/show/NCT05178810
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with amyotrophic lateral sclerosis.
Find out more: https://classic.clinicaltrials.gov/ct2/show/NCT05866926
Sponsor
Ferrer Internacional S.A.
Investigator
National coordinator : Pr Philippe Corcia
Status
Completed
